Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT00405405
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2006-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D010307', 'term': 'Parotid Neoplasms'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2006-11-29', 'studyFirstSubmitQcDate': '2006-11-29', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer', 'timeFrame': 'Day 36', 'description': 'To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.'}], 'secondaryOutcomes': [{'measure': 'Determination of Dose Limiting Toxicity (DTL)', 'timeFrame': '30 days', 'description': 'To determine the appropriate dosing strategy for bevacizumab/erlotinib when combined with chemoradiotherapy for advanced head and neck cancer.'}, {'measure': 'Complete Remission Rate', 'timeFrame': '6 months', 'description': 'To obtain preliminary data on the complete remission rate for this treatment combination.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Head and neck cancer', 'Parotid gland cancer', 'thyroid gland cancer', 'melanoma', 'Chemoradiotherapy', 'bevacizumab', 'erlotinib'], 'conditions': ['Head and Neck Cancer', 'Parotid Gland Cancer', 'Thyroid Gland Cancer', 'Melanoma', 'Stage IV Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.KimmelCancerCenter.org', 'label': 'Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer', 'detailedDescription': 'Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease.\n\nThe proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy. Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced Carcinoma (epithelial malignancy) of the head and neck. This may include non-squamous carcinomas (e.g. parotid, thyroid, melanoma) in which a large portion of mucosa of the oral cavity and/or laryngopharynx is expected to be irradiated.\n* Stage IV disease (T4Nany or TanyN2-3).\n* "Oligometastatic" disease is allowable if it is asymptomatic.\n* Measurable disease is not required; patients who have had surgical resection are eligible provided that it is felt that the likelihood of cure with conventional postoperative therapy is \\<40% and provided that there will be at least 28 days from the date of surgery to the start of study therapy.\n* Performance status 0-1.\n* Creatinine \\< or = 1.5 mg/dl.\n* ANC \\> or = 1,800 cells/mm3.\n* Platelets \\> or = 150,000 cells/mm3.\n* Hemoglobin \\> or = 10 g/dl (transfusion is acceptable if needed).\n* SGOT and/or SGPT \\< or = 2.5 times the upper institutional limit of normal.\n* INR \\< or = 2.0.\n* Age \\> or = 18 (informed consent).\n\nExclusion Criteria:\n\n* Current, recent (within 4 weeks of the Day 1, the first infusion of drug in this study) or planned participation in an experimental drug study other than this one.\n* Poorly controlled blood pressure, defined as systolic bp \\> 150 and/or diastolic bp \\> 100 despite medication.\n* Unstable angina.\n* NY Heart Association (NYHA) Grade II or greater congestive heart failure.\n* History of myocardial infarction or stroke within 6 months.\n* Clinically significant peripheral vascular disease.\n* Evidence of bleeding diathesis or coagulopathy.\n* Presence of brain or spinal cord metastases.\n* Major surgical procedure(s), open biopsy or significant traumatic injury within 28 days prior to Day 1 (1st day of study treatment) and/or anticipation of need for major surgical procedure during the course of the study.\n* Urine protein: Creatinine ratio \\> or = 1.0 at screening.\\*\n* Carotid artery exposure or other signs of impending carotid artery hemorrhage.\n* History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment.\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Prior irradiation that would result in radiotherapy field "overlap."\n* Requirement for high dose oral anticoagulation (i.e., goal INR \\> 2.0). "Mini-dose" anticoagulation as may be used to assist in patency of central venous lines is acceptable. Subcutaneous Low-molecular weight heparin is allowable.\n* No known allergies to any of the drug therapies being used in this protocol.\n* No pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.'}, 'identificationModule': {'nctId': 'NCT00405405', 'briefTitle': 'Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer', 'orgStudyIdInfo': {'id': '06C.46'}, 'secondaryIdInfos': [{'id': '2005-58', 'type': 'OTHER', 'domain': 'CCRRC'}, {'id': '06C.46', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy', 'interventionNames': ['Drug: Cisplatin', 'Drug: Docetaxel', 'Drug: Bevacizumab', 'Drug: Erlotinib', 'Radiation: Radiotherapy']}], 'interventions': [{'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['cisplatinum', 'cis-diamminedichloroplatinum(II)', 'CDDP', 'Platinol', 'Platinol-AQ'], 'description': '* Two cycles during neoadjuvant therapy\n* Response assessment at approximately day 36\n* Concurrent biochemoradiotherapy', 'armGroupLabels': ['Treatment']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': '* Two cycles during neoadjuvant therapy\n* Response assessment at approximately day 36\n* Concurrent biochemoradiotherapy', 'armGroupLabels': ['Treatment']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': '* Two cycles during neoadjuvant therapy\n* Response assessment at approximately day 36\n* Concurrent biochemoradiotherapy', 'armGroupLabels': ['Treatment']}, {'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Erlotinib hydrochloride', 'Tarceva'], 'description': '* Two cycles during neoadjuvant therapy (dose escalation)\n* Response assessment at approximately day 36\n* Concurrent biochemoradiotherapy', 'armGroupLabels': ['Treatment']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'otherNames': ['Radiation therapy', 'Radiation oncology', 'XRT'], 'description': 'Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Pramila Rani Anne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}